Job Title:
CRA II (Clinical Research Associate II)
Location:
Taiwan – Client Site
Job ID:
25102411
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company leverages clinical, medical affairs, and commercial insights to drive outcomes.
Highlights:
Patient- and client-centric clinical development model
Agile, collaborative, and innovative work environment
29,000 employees across 110 countries
Inclusive Total Self culture promoting authenticity and belonging
Job Summary:
CRA II is responsible for overseeing and ensuring the integrity of clinical research studies through site qualification, initiation, monitoring, and close-out activities. The role applies both on-site and remote monitoring strategies and collaborates with site teams to enhance quality and compliance with ICH-GCP, GPP, and other applicable regulations.
Key Responsibilities:
Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote)
Evaluate site performance and staff, providing recommendations and action plans for site-specific issues
Verify informed consent processes and protect patient confidentiality
Assess factors affecting patient safety and data integrity, including protocol deviations and pharmacovigilance issues
Conduct Source Document Review and verify CRF data accuracy and completeness
Apply query resolution techniques and guide site staff to close queries within timelines
Ensure compliance with electronic data capture requirements
Manage investigational product (IP) inventory, storage, and reconciliation; verify protocol-compliant dispensing
Review Investigator Site File (ISF) and reconcile with Trial Master File (TMF)
Document activities via trip reports, follow-up letters, and communication logs
Support patient recruitment, retention, and awareness initiatives
Track project scope, budgets, timelines, and site-level communications to meet objectives
Act as liaison with study site personnel or Central Monitoring Associate
Participate in Investigator Meetings, sponsor meetings, and global clinical project staff meetings
Support audit readiness and follow-up actions
For Real World Late Phase studies (SMA II):
Provide site support throughout the study lifecycle
Conduct chart abstraction and data collection
Collaborate with sponsor affiliates, medical liaisons, and local staff
Train junior staff and identify out-of-scope activities
Suggest potential sites based on local knowledge of treatment patterns and HCP networks
Qualifications:
Bachelor’s degree or RN in a related field, or equivalent combination of education and experience
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements
Strong computer skills and ability to adopt new technologies
Excellent communication, presentation, and interpersonal skills
Ability to travel up to 75% regularly
Impact and Contribution:
Ensures the integrity and quality of clinical research studies using centralized monitoring, risk-based techniques, and compliance checks
Contributes to the design, implementation, and delivery of processes, tools, and SOPs to enhance trial quality
Collaborates with site teams to improve monitoring efficiency and trial success
Acts as a key individual contributor, potentially managing small components of projects or junior staff
Plays a critical role in patient safety, data quality, and overall clinical trial outcomes
Job Category:
Clinical Operations / Clinical Monitoring / CRA
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